(127 days)
[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of prosthetic restorations on implant abutments and frames
[3] Cementation of adhesion bridges and splints
[4] Cementation of posts and cores
[5] Amalgam bonding
PANAVIA SA Cement Universal is a dual-cure (light- and/or self-cure), fluoride releasing, radiopaque self-adhesive resin cement for ceramic (porcelain, lithium disilicate, zirconia, etc.), composite resin, and metal restorations. It has a choice of Automix delivery (equal amounts of two components are combined through a mixing tip) or Handmix (equal amount of two components are combined on a mixing pad).
This document describes the premarket notification for the PANAVIA SA Cement Universal dental cement.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are generally based on compliance with ISO 4049:2009 (Dentistry - Polymer-based restorative and materials) and a comparative study against a predicate device.
| Acceptance Criteria (ISO 4049:2009 Sections) | Reported Device Performance (PANAVIA SA Cement Universal - Handmix) | Predicate Device Performance (PANAVIA SA Cement Plus Automix) |
|---|---|---|
| 5.2.2 Film thickness, luting materials | COMPLIES | COMPLIES |
| 5.2.4 Working time, Class 1 and Class 3 luting materials | COMPLIES | COMPLIES |
| 5.2.6 Setting time, Class 3 materials | COMPLIES | COMPLIES |
| 5.2.9 Flexural strength | COMPLIES | COMPLIES |
| 5.2.10 Water sorption | COMPLIES | COMPLIES |
| 5.2.10 Solubility | COMPLIES | COMPLIES |
| 5.4 Color stability after irradiation and water sorption | COMPLIES | COMPLIES |
| 5.5 Radio-opacity | COMPLIES | COMPLIES |
| Bond Strength to Tooth dentin | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Bond Strength to Tooth enamel | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Bond Strength to Ceramic | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Bond Strength to Metal | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Bond Strength to Titan | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Bond Strength to Composite resin | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Bond Strength to Amalgam | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Released fluorine ion | Substantially equivalent to predicate | Predicate performance |
2. Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test in the comparative study (e.g., number of samples for film thickness, strength, bond strength measurements).
The data provenance is from non-clinical testing performed by the manufacturer, Kuraray Noritake Dental Inc., in Japan. The studies are retrospective in the sense that they are laboratory tests conducted to compare the new device against an already marketed predicate device, rather than a clinical trial with human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This is a non-clinical, laboratory-based study comparing a new dental cement to a predicate device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical diagnostics or image interpretation does not directly apply. The "ground truth" for these tests is established by adherence to the specifications and methodologies outlined in ISO 4049:2009 for physical and mechanical properties, and internal standards for bond strength. The expertise lies in the laboratory technicians and scientists performing and evaluating these standardized tests. No specific number or qualifications of "experts" are listed for establishing ground truth in this context.
4. Adjudication Method for the Test Set:
No adjudication method (e.g., 2+1, 3+1) is mentioned or applicable as this is a non-clinical laboratory study, not a study evaluating human interpretation of data. The results are obtained through standardized measurements and comparisons.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is typically used for medical imaging devices where human readers interpret images. This document describes a dental cement, and its evaluation focuses on physical, mechanical, and chemical properties, not human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
Not applicable. PANAVIA SA Cement Universal is a dental cement, not an algorithm or a device requiring human-in-the-loop performance in the context of AI. The performance is the inherent material properties of the cement.
7. Type of Ground Truth Used:
The ground truth used for performance validation is:
- International standards: Specifically, compliance with the requirements outlined in ISO 4049:2009 (Dentistry - Polymer-based restorative and materials) for various physical and mechanical properties.
- Comparative equivalence to a legally marketed predicate device: The subject device's performance (bond strength, fluorine ion release) was compared directly to PANAVIA SA Cement Plus Automix, demonstrating non-inferiority or substantial equivalence.
- In-house standards: For bond strength tests, "In-house standard" was used for assessment.
8. Sample Size for the Training Set:
Not applicable. This is a dental material, not a machine learning algorithm that requires a training set. The term "training set" is typically used in the context of artificial intelligence/machine learning model development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a dental cement product.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
April 25, 2019
Kuraray Noritake Dental Inc. Yasuiiro Ohara Manager Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda-ku, Tokyo 100-0004 JAPAN
Re: K183537
Trade/Device Name: PANAVIA SA Cement Universal Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA, KLE Dated: January 24, 2019 Received: January 28, 2019
Dear Yasujiro Ohara:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
{1}------------------------------------------------
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Srinivas Nandkumar -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K183537
Device Name: PANAVIA SA Cement Universal
Indications for Use:
PANAVIA SA Cement Universal is indicated for the following uses:
[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of prosthetic restorations on implant abutments and frames
[3] Cementation of adhesion bridges and splints
[4] Cementation of posts and cores
[5] Amalgam bonding
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{3}------------------------------------------------
January 24th, 2019 Date:
K183537
510(k) Summary
3-1. 510(k) owner (submitter)
| 1) Name | Kuraray Noritake Dental Inc. | ||
|---|---|---|---|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan | ||
| 3) Contact person | Yasujiro OharaQuality Assurance Department | ||
| 4) Contact person in US | Manabu SuzukiKURARAY AMERICA, INC.33 Maiden Lane, 6th Floor, New York, NY 10038Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676Fax: (212)-867-3543 | ||
| 3-2. Name of Device | |||
| 1) Trade / Proprietary name | PANAVIA SA Cement Universal | ||
| 2) Classification name | Dental cement(21 CFR section 872.3275. Product code: EMA) | ||
| 3) Common name | Dental adhesive resin cement | ||
| 3-3. Predicate device | |||
| 1) | PANAVIA SA Cement Plus Automix | 510(k) NumberClassification:Product Code:21 CFR Section:Applicant: | K142625Dental cementEMA872.3275Kuraray Noritake Dental Inc. |
| 3-4. Reference devices | |||
| 1) | CLEARFIL MAJESTY ES Flow | 510(k) Number:Classification:Product Code:21 CFR Section:Applicant: | K130371Tooth shade resin materialEBF872.3690Kuraray Noritake Dental Inc. |
| 2) | PANAVIA SA Cement Plus Handmix | 510(k) Number:Classification:Product Code:21 CFR Section:Applicant: | K142623Dental cementEMA872.3275Kuraray Noritake Dental Inc. |
3-5. Device Description
PANAVIA SA Cement Universal is a dual-cure (light- and/or self-cure), fluoride releasing, radiopaque self-adhesive resin cement for ceramic (porcelain, lithium disilicate, zirconia, etc.), composite resin, and metal restorations. It has a choice of Automix delivery (equal amounts of two components are combined through a mixing tip) or Handmix (equal amount of two components are combined on a mixing pad). This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.
{4}------------------------------------------------
3-6. Statement of Intended Use
PANAVIA SA Cement Universal is indicated for the following uses:
[1] Cementation of crowns, bridges, inlays and onlays
- [2] Cementation of prosthetic restorations on implant abutments and frames
- [3] Cementation of adhesion bridges and splints
- [4] Cementation of posts and cores
- [5] Amalgam bonding
3-7. Substantial Equivalence Discussion
1) Intended uses
Intended uses of the subject device and predicate devices, PANAVIA SA Cement Plus Automix which is self-adhesive resin cement which is dental resin cement, is as listed on the following table.
| Trade name | Intended use | |
|---|---|---|
| Subjectdevice | PANAVIA SACement Universal | [1] Cementation of crowns, bridges, inlays and onlays[2] Cementation of prosthetic restorations on implant abutmentsand frames |
| Predicatedevice | PANAVIA SACement Plus Automix | [3] Cementation of adhesion bridges and splints[4] Cementation of posts and cores[5] Amalgam bonding |
The intended use of the subject device is the same as that of the predicate device. Therefore, the intended use of the subject device is substantially equivalent to that of the predicate device.
2) Chemical ingredients/ Safety
All ingredients in the subject device have been used in the predicate device and reference devices. Regarding the predicate device and reference devices, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US. From the above, it was concluded that the subject device is substantially equivalent in biological safety to the predicate device and reference devices.
- Technological characteristics/ Effectiveness and Performance
Physical and mechanical properties of the subject device were evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials).
{5}------------------------------------------------
The results of comparative study performed according to ISO 4049: 2009 were indicated below.
| Section | PANAVIA SA Cement Universal (Handmix)(Subject device) | PANAVIA SA Cement Plus Automix(Predicate device) | |||
|---|---|---|---|---|---|
| Shade type:Universal (A2) | Shade type:White | Shade type:Universal (A2) | Shade type:White | ||
| 5.2.2 Film thickness, luting materials | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.2.4 Working time, Class 1 and Class 3 luting materials | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.2.6 Setting time, Class 3 materials | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.2.9 Flexural strength | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.2.10 Water sorption and solubility | Water sorption | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| Solubility | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.4 Color stability after irradiation and water sorption | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.5 Radio-opacity | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
The results indicate that the subject device and the predicate device comply with the requirements of ISO 4049: 2009. From the above, it can be said that comparative study of the subject device is substantially equivalent to that of the predicate device.
{6}------------------------------------------------
| Adherend surface(Material composition) | Criteria | Subject device(Handmix) | Predicate device | |
|---|---|---|---|---|
| Tooth dentin | In-housestandard | COMPLIES | COMPLIES | |
| Tooth enamel | COMPLIES | COMPLIES | ||
| Ceramic | COMPLIES | COMPLIES | ||
| Metal | COMPLIES | COMPLIES | PANAVIA SA CementPlus Automix | |
| Titan | COMPLIES | COMPLIES | ||
| Composite resin | COMPLIES | COMPLIES | ||
| Amalgam | COMPLIES | COMPLIES |
The result of Bond strength test
The bond strengths to all substrates of the subject device were not statistically (P>0.05) different from that of the predicate device.
Therefore, it was concluded that the bonding performance to all substrates of the subject device was equivalent to that of the predicate device.
Released fluorine ion test was performed to validate the substantial equivalence of the subject device with the predicate device.
It was concluded that amount of released fluorine ion from the subject device is substantially equivalent to that of the predicate device.
3-8. Biocompatibility
The subject device is classified according to ISO 7405:2008 and ISO 10993-1:2009 as an external communicating device that will have permanent (> 30 days) contact with tissues.
All ingredients in the subject device have been used in the predicate device and the reference devices as listed on the "Table 7-5-1.and 7-5-2." in "Section 7: Substantial Equivalence Discussion". And those devices are also classified as an external communicating device that will have permanent (> 30 days) contact with tissues.
Regarding the predicate device and the reference devices, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US.
Concerning the track records of the ingredients, intended use, manufacturing process, contact part and contact duration, all of them are substantially equivalent to those of the predicate device and the reference devices.
These facts lead us to conclude that the subject device is substantially equivalent in biocompatibility to the predicate device and the reference devices without performing additional biological tests.
3-9. Conclusion
The comparison for intended uses, chemical ingredients/ safety and performance data shows that the subject device is substantially equivalent to the predicate device and the reference devices. This submission information including the nonclinical testing provided supports that the subject device is as safe and as effective as the predicate device and the reference devices.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.